New Delhi: Import of high end and high value used (second hand) medical equipments including surgical robot has landed in controversy. Alleging it to be illegal and in the flagrant violation of government regulation, a consumer group named Patient Safety And Access Initiative of India Foundation (PSAIIF) has filed a writ petition in the nature of a PIL in Delhi High Court. The consumer group has also named American medical equipment company Intuitive, the maker of Da Vinci Surgical robot in its PIL.
Citing grave danger to safety of patients, PIL also contends that it goes against the clearly stated Make in India policy of Indian government. As this involves surgical robot Major Intuitive, the ramifications of upcoming potential PIL might be far reaching in India as Da Vinci surgical robot is rapidly make it to Indian hospitals. Many robotic surgeons said that The PIL might put a spoke in Da Vinci’s wheel. It is to be noted that robotic surgery is catching up fast in India.
The Hon’ble Delhi High Court today (May 30) heard the Writ Petition in public interest filed by Patient Safety and Access Initiative of India Foundation seeking action against large scale import of “High-End And High-Value Used Medical Equipment Other Than Critical Care Medical Equipment” (“Refurbished HEHV Medical Equipment”) into India without following the mandatory regulations, including prior approval of the Ministry of Environment, Forest and Climate Change (“MoEFCC”), which is mandatory. The Petition relied on extensive data to illustrate that just one company, i.e. Intuitive India Private Limited (presumably, a subsidiary of Intuitive Surgical Inc, USA) itself had imported items over INR 250 crores since 2019, presumably without the mandatory approval of the MoEFF.
The Hon’ble Delhi High Court granted liberty to the Petitioner to file a representation to the relevant authorities, and the Hon’ble Court directed the Respondent authorities, i.e. Ministry of Health and Family Welfare, MoEFCC, Central Board of Indirect Taxes and Customs and Directorate General Of Foreign Trade to decide on the representation, if any, made by the Petitioner. The Petition was argued by Mr. Sandeep Sethi, Senior and filed by Karan Gupta, Partner, KGVS Legal LLP, a law firm based out of Defence Colony, New Delhi.
PSAIIF’s stand arises from concerns regarding the laxity in the regulatory framework concerning the quality, safety and efficacy assessment of second-hand or used medical devices, which are compromising the standard of health services in the country. The script of PIL states, ‘ The cause of action also arises in view of refurbished medical devices posing an inherent safety risk to the life of the general public at large, who are being operated/diagnosed in hospitals using these perused /refurbished/reconditioned medical devices. The cause of action in the nature of a Public Interest Litigation inter alia also arises from the risks associated with India being made a dumping ground for such pre used/refurbished/reconditioned medical devices which are considered obsolete in their country of origin. The petition has thus been filed for the benefit of the public in general who may be incapable of accessing the court.
The impending PIL has enumerated a number of reasons in support of its contention against illegal import of high end medical equipments including Da Vinci. Some of them are as follows.
The recent OMs from Various Govt of India Institutions are a regressive step that has confused the investors who have been putting up manufacturing capacity in the last few years in response to PM Modi’s call for self-reliance, resulted in ‘Un-make in India’ campaign amounts to bulldozing the Make in India dream of Prime Minister Narendra Modi.
The some of the overseas multinational companies are importing refurbished/reconditioned medical devices illegally importing worth more than 250 Crores without approvals, such as robotic Surgical systems from Intuitive Surgical Inc, USA, Radiology Equipments from Europe, China, USA into India and the list is more as per the sources and dumping such equipment in India which is obsolete and contains outdated technology with greater safety risks. This is posing a serious threat for the patients in India and is thus in violation of Article 21 of the Constitution of India, 1950.
The failure to effectively implement the Office Memorandums and place appropriate conditions for the import of refurbished/reconditioned High End High Value Medical Equipment into India prior to granting approval, including taking into account the condition that “equipment manufactured in India should not be imported, as per ‘Make in India’ policy” is in blatant violation ofArticle 14, 19, and 21 of the Constitution of India.
The import of Refurbished Medical Equipment into India without prior approval of the MoEFCC results in outdated and obsolete medical devices being imported into India and being utilized for patient care without any proper evaluation of the condition of the said equipment, thereby posing serios threat to life and safety of the patients in India.
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